An interventional study of Chronotype and Green exercise in Migraine Disorders, sponsored by University of Nevada, Las Vegas. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-28.
Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Treatment
Chronic pain, of which migraine is among the most common, affects 100 million US adults and costs between $560 to $635 billion dollars annually. There is a need for effective, low-cost non-pharmacological strategies to reduce migraine load in migraineurs (based on International Headache Society classification International Classification of Headache Disorders [ICHD]-3; experience headache [migraine-like or tension-type-like] on 15+ days/month for 3+ months, and have migraine headaches [either with aura or without aura] on 8+ days/month). This represents an area of interest, as common migraine medications induce central nervous system side-effects including aphasia, ataxia, somnolescence, and vertigo; and 79% of suffers have an interest in trying novel treatment strategies with lower adverse effects than medications.
Exercise has been shown to be a non-pharmacological intervention to reduce migraine burden. However, how environmental (i.e. - time-of-day, exposure to nature) and genetic factors (i.e. - polymorphisms in circadian and migraine associated genes) impact the laudatory effects of exercise remains unknown. There are independently established heritable components to migraine frequency (65%), circadian rhythm (70%), and aerobic power during exercise (66%). Thus, the central hypothesis is that an optimal environment can improve the exercise-induced reduction in migraine load, which is influenced by genetic heritability of migraine related gene polymorphisms.
Willing participants who are self-reported chronic migraineurs will complete an informed consent followed by a health risk questionnaire to determine study eligibility.
Phase I: Chronic migraineurs will be screened using the Morningness/Eveningness Questionnaire (MEQ) to recruit a cohort of discrepant chronotypes (Definite Morning, Morning; and Evening, Definite Evening). Resulting participants will be complete a baseline migraine load evaluation and assigned to four weeks of moderate intensity exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) consolidated to either the morning (before 09:00) or afternoon (after 17:00) in a randomized cross-over design. Intensity will be tracked through a heart rate monitor that will be provided to participants, and an application that they can download to their phone. Participants will be able to keep the heart rate monitor upon completion of the study. An example of potential exercises will be provided to participants and research team members will check in every 1-2 weeks to see how exercise is progressing. Migraine burden will be assessed pre- and post-training after each condition using the Migraine Disability Assessment (MIDAS) and the short version of the Headache Impact Test (HIT-6). Half of the participants will exercise for one month during a time of day that is in sync with their chronotype (i.e. Morning type person will exercise in the morning), and the other half of the participants will exercise at a time of day that is not in sync (i.e. Morning type person will exercise in the evening). There will be a one-month wash out period, and then participants will complete training at the other time of day. A buccal swab will be obtained (according to protocols outlined on our approved Institutional Biosafety Committee protocol) for phenotyping of genes specific to chronotype and migraine.
Phase II will also recruit chronic ICHD-3 migraineurs. Participants will complete a baseline migraine load evaluation as described above. If an effect of chronotype is found in Phase I, participants will complete exercise training in sync with their chronotype. Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. Intensity will be tracked through a heart rate monitor that will be provided to participants, and an application that they can download to their phone. Participants will be able to keep the heart rate monitor upon completion of the study. An example of potential exercises will be provided to participants and research team members will check in every 1-2 weeks to see how exercise is progressing. A recent investigation provided evidence that activity performed in a desert environment provided the same benefits as in a green landscape with respect to both cardiovascular measures as well as perception of comfort, calm, and perceived stress. Half of the participants will exercise for one month in a natural environment that they select (outdoors in a park, or trail) and the other half will complete exercise indoors (participants will not require access to fitness facilities, although these could be used if they are already a member). There will be a one month wash out period, and then participants will complete exercise training in the other setting. Change in the monthly migraine load will be determined between environments. A buccal swab will be obtained for phenotyping of genes specific to chronotype and migraine.
Buccal swab samples will be used to isolate DNA. Isolated DNA will be genotyped at the University of Nevada, Las Vegas (UNLV) Genomics Core Facility using polymerase chain reaction and then disposed of. Genotypes will be linked to participant migraine load responses, and then reported in aggregate.
The investigators plan to maintain regular contact with participants. After each exercise bout, participants will download and email the associated csv file which will be received, deidentified, and labelled with the participant identification number for digital storage at UNLV. In response, participants will be asked about the exercise sessions (with open ended questions such as "How do you feel the exercise sessions are going?"). The file will be reviewed upon receipt by a member of the research team to determine exercise intensity (60-70% estimated heart rate range), allow the investigators to provide feedback, and also enable the determination of how well participants are adhering to the intervention. The investigators will use the Polar Flow application (available for free), which can be deleted by the participant at the end of the study if they so choose.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 18 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Determination whether monthly migraine load is affected by exercise in sync with chronotype
Behavioral: Chronotype
Determination whether monthly migraine load is affected by exercise in a natural environment
Behavioral: Green exercise
Participants screened using the Morningness/Eveningness Questionnaire. Chronotype categorized as either Definite Morning/Morning, or Evening/Definite Evening. Participant will exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) either in sync or not in sync with chronotype for one month in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in the alternate chronotype for one month.
Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in alternate environment for one month.
Migraine load difference (evaluated by MIDAS) when exercising in sync with chronotype versus not in sync
The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.
Time frame: Three months
Migraine load difference (evaluated by HIT-6) when exercising in sync with chronotype versus not in sync
The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.
Time frame: Three months
Migraine load difference (evaluated by MIDAS) when exercising in nature versus indoors
The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.
Time frame: Three months
Migraine load difference (evaluated by HIT-6) when exercising in nature versus indoors
The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.
Time frame: Three months
Plan to share: Yes — Individual participant data that underlie the results, after deidentification.
Supporting information: Study protocol
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University of Nevada, Las Vegas